None listed
Conditions
Brief summary
This project is testing the safety, pharmacokinetics (PK, the amount of study drug in your blood), and pharmacodynamics of single intravenous doses of a new drug called EARLI-001. EARLI-001 is a method for the detection of cancers. Who is it for? You may be eligible for this study if you are an adult man or woman over the age of 18 who has been newly diagnosed with locally advanced or metastatic lung cancer. Study details Participants will receive a single dose of EARLI-001 at one of 4 different dose levels. EARLI-001 will be given to you intravenously. Total participation will last up to 60 days which includes 8 visits to the clinic for assessments and to collect blood and urine samples. It is hoped that this research will help determine the safety of EARLI-001 when given to patients with lung cancer.
Interventions
Up to 30 subjects with locally advanced or metastatic lung cancer will be enrolled in this study in up to 4 cohorts. Subjects within each cohort will receive a single dose of EARLI-001 given by intravenous administration. The doses will be administered in the clinic to ensure adherence.
The doses to be administered are noted below:
Cohort 1 - 0.003 mg/kg
Cohort 2 - 0.013 mg/kg
Cohort 3 - 0.054 mg/kg
Cohort 4 (Expansion Cohort) - The cohort 4 dose is to be determined and will be the highest toler
Up to 30 subjects with locally advanced or metastatic lung cancer will be enrolled in this study in up to 4 cohorts. Subjects within each cohort will receive a single dose of EARLI-001 given by intravenous administration. The doses will be administered in the clinic to ensure adherence. The doses to be administered are noted below: Cohort 1 - 0.003 mg/kg Cohort 2 - 0.013 mg/kg Cohort 3 - 0.054 mg/kg Cohort 4 (Expansion Cohort) - The cohort 4 dose is to be determined and will be the highest tolerable dose or a lower alternate dose as selected by the Principal Investigators and Sponsor
Sponsors
Earli, Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent prior to the initiation of any study-specific procedures. 2. Males and females aged 18 years or older at time of consent 3. Histologically or cytologically confirmed locally advanced or metastatic lung cancer. Subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer may also be considered for inclusion 4. Expected survival greater than 3 months 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Body mass index (BMI) less than or equal to 32.0 kg/m2 7. Adequate organ and marrow function based on clinical laboratory assessments 8. Female subjects must be of non-childbearing potential 9. Male patients must use highly effective contraception methods consisting of 2 forms of birth control starting at screening and continuing throughout the study period and for 3 months after the last study treatment
Exclusion criteria
1. Females of child-bearing potential or who are breastfeeding or who have a positive pregnancy test 2. Has a known severe hypersensitivity to any of the excipients in the formulation of EARLI-001. 3. Has a clinically significant history or presence of ECG findings as judged by the PI or designee at screening 4. Has received treatment within 30 days or 5 half-lives (whichever is greater) before dosing for their current diagnosis of histologically or cytologically confirmed locally advanced or metastatic lung cancer or their current diagnosis with metastases in the lung or liver of a primary cancer origin other than lung cancer. Subjects will be permitted to start on an approved treatment after the Day 8 assessments have been completed. 5. Has received treatment with another investigational drug, or investigational device, within 30 days or 5 half-lives (whichever is longer) before dosing. 6. Is currently taking heparin, or a heparin analog. 7. Has signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol. 8. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements 9. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the patient unsuitable for enrollment.
Outcome results
None listed